Antineoplaston Therapy in Treating Patients With Stage IV Melanoma

Launched by BURZYNSKI RESEARCH INSTITUTE · Jan 26, 2003

Keywords

ClinConnect Summary

Stage IV Melanoma patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stage IV Melanoma, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with Stage IV Melanoma.
* To determine ob...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically confirmed stage IV melanoma that is recurrent or progressing and unlikely to respond to existing therapy
• • Measurable disease by MRI or CT scan
• • Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations
• PATIENT CHARACTERISTICS:
• Age:
• • 18 and over
• Performance status:
• • Karnofsky 60-100%
• Life expectancy:
• • At least 2 months
• Hematopoietic:
• • WBC at least 2,000/mm3
• • Platelet count at least 50,000/mm3
• Hepatic:
• • Bilirubin no greater than 2.5 mg/dL
• • SGOT and SGPT no greater than 5 times the upper limit of normal
• • No hepatic insufficiency
• Renal:
• • Creatinine no greater than 2.5 mg/dL
• • No renal insufficiency
• • No renal conditions that contraindicate high dosages of sodium
• Cardiovascular:
• • No chronic heart failure
• • No uncontrolled hypertension
• • No history of congestive heart failure
• • No other cardiovascular conditions that contraindicate high dosages of sodium
• Pulmonary:
• • No severe lung disease, such as chronic obstructive pulmonary disease
• Other:
• • Not pregnant or nursing
• • Fertile patients must use effective contraception during and for 4 weeks after study
• • No serious medical or psychiatric disorders
• • No active infection
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• • At least 4 weeks since prior immunotherapy and recovered
• • No concurrent immunomodulating agents
• Chemotherapy:
• • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
• • No concurrent antineoplastic agents
• Endocrine therapy:
• • Concurrent corticosteroids allowed
• Radiotherapy:
• • At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks)
• Surgery:
• • Recovered from prior surgery
• Other:
• • Prior cytodifferentiating agent allowed
• • No prior antineoplaston therapy